FDA Halts Allogene’s CAR-T Therapy Studies

October 12, 2021

Following a report of a chromosomal abnormality in a patient, the FDA has placed a hold on Allogene Therapeutics’ early-stage chimeric antigen receptor T (CAR-T) therapy clinical trials.

The chromosomal abnormality was detected in a bone marrow biopsy done to assess low blood counts. The patient with stage IV transformed follicular lymphoma had received two prior lines of immune-chemotherapy and additional radiation therapy, Allogene said, adding that the patient subsequently underwent allogeneic stem cell transplantation.

An investigation is underway to further characterize the abnormality, including any potential relationship to gene editing, the company said.

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